Zentalis Pharmaceuticals Announces Four Azenosertib Posters Presentations at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

Rhea-AI Summary

Zentalis (Nasdaq: ZNTL) announced four azenosertib poster presentations at the AACR‑NCI‑EORTC International Conference on Molecular Targets and Cancer Therapeutics, held October 22–26, 2025 in Boston.

Presentations include Phase 1 dose escalation/expansion results, Cyclin E1 biomarker findings supporting late‑stage development in Cyclin E1‑positive platinum‑resistant ovarian cancer (noted as ~50% of PROC), a trial‑in‑progress DENALI Part 2 biomarker study (GOG‑3066), and a trastuzumab deruxtecan + azenosertib combination study in HER2‑expressing tumors. Posters are scheduled October 23–24, 2025 and will be available via Zentalis' Publications page on the presentation days.

Insights

Clinical Development Strategist

Phase 1 data and Cyclin E1 biomarker findings support advancement of azenosertib toward later‑stage trials; multiple presentations increase scientific visibility.

Zentalis advances evidence for azenosertib via four poster presentations at the AACR‑NCI‑EORTC conference on October 22-26, 2025, including Phase 1 dose escalation/expansion results and Cyclin E1 biomarker analyses. The Phase 1 dataset and biomarker correlation form the mechanistic basis for a biomarker‑driven pathway in Cyclin E1‑positive platinum‑resistant ovarian cancer, an indication the company highlights as representing ~50% of PROC patients.

The key dependencies are the statistical strength and reproducibility of the Phase 1 biomarker signal, and how those data translate into predefined endpoints for the planned or ongoing later‑stage trials, including the DENALI Part 2 study. Presentations about combination regimens and earlier‑line settings broaden development options but depend strictly on confirmatory clinical endpoints and trial design details shared at or after the conference.

Watch for the full poster data on the company website on presentation days and for protocol details or enrollment milestones for the DENALI study and the combination trial in the weeks following October 23-24, 2025; these items will provide concrete, monitorable signals about whether the Phase 1 biomarker findings will materially support late‑stage development.

Presentations feature data from first-in-human Phase 1 study including Cyclin E1 biomarker findings, supporting late-stage development of azenosertib

SAN DIEGO, Oct. 13, 2025 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company developing a potentially first-in-class WEE1 inhibitor for patients with ovarian cancer and other tumor types, today announced that four azenosertib abstracts have been accepted for poster presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place October 22-26, 2025 at the Hynes Convention Center in Boston, Massachusetts.

“The Phase 1 results and Cyclin E1 biomarker findings accepted for presentation at AACR-NCI-EORTC reinforce our biomarker-driven strategy for azenosertib in Cyclin E1-positive platinum-resistant ovarian cancer patients, an underserved patient population representing approximately 50% of PROC patients,” said Dr. Ingmar Bruns, Chief Medical Officer of Zentalis. "Beyond our core focus on this indication, our presentations also highlight the potential of azenosertib as a combination therapy and in earlier lines of ovarian cancer, suggesting expansion opportunities with our WEE1 inhibition approach.”

Abstract and Presentation Details
Title: "Results From the Phase 1 Dose Escalation and Dose Expansion Study of Azenosertib, a WEE1 Inhibitor, in Patients With Advanced Solid Tumors"
Date/Time: Friday, October 24, 2025, 12:30-4:00 p.m. EDT
Presenter: Funda Meric-Bernstam, MD, Department Chair, Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX
CTI: NCT04158336

Title: "Rationale for the use of Azenosertib in Early Line Treatment of Cyclin E1-Positive High-Grade Serous Ovarian Cancer"
Date/Time: Thursday, October 23, 2025, 12:30-4:00 p.m. EDT
Presenter:  Mona Abed, PhD, Associate Director, Translational Biology at Zentalis

Title: "Trial in Progress: Cyclin E1 Positive Protein Status is a Predictive Biomarker of Azenosertib Benefit in Platinum-Resistant Ovarian Cancer: Part 2 of the DENALI Study (GOG-3066)"
Date/Time: Friday, October 24, 2025, 12:30-4:00 p.m. EDT
Presenter:  Carol Josephs-Cowan, MSN, ANP, Executive Director, Medical Affairs at Zentalis
CTI: NCT05128825

Title: "Trial in Progress: Phase 1 Study of Trastuzumab Deruxtecan (DS-8201a) in Combination with Azenosertib (ZN-c3) in HER2-Expressing/Amplified Gastric/Gastroesophageal Junction Cancer and Other Solid Tumors with HER2 Expression"
Date/Time: Friday, October 24, 2025, 12:30-4:00 p.m. EDT
Presenter: Alexandria Doerfler, PhD, Supervisor, Clinical Studies at MD Anderson Cancer Center
CTI: NCT06364410

The posters can be accessed through the Publications page of the Zentalis website on the day of the presentations.

About Azenosertib
Azenosertib is a novel, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated as a monotherapy and combination clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.

About DENALI Clinical Trial
DENALI is a multi-part Phase 2 clinical trial studying azenosertib in platinum-resistant ovarian cancer (PROC) patients. Part 1b enrolled patients with PROC regardless of Cyclin E1 protein expression, all treated at 400mg 5:2 (intermittent daily dosing with five days on, two days off dosing schedule). Interim results from Part 1b were presented at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting. Part 2 is ongoing and is enrolling PROC patients with Cyclin E1 protein overexpression based on Zentalis' proprietary immunohistochemistry cutoff. Part 2 includes Part 2a, a dose confirmation portion evaluating two doses, 300mg 5:2 and 400mg 5:2, and Part 2b, a portion designed to complete enrollment at the selected dose. Part 2, in total, is designed for accelerated approval, pending study outcome and discussions with the U.S. Food and Drug Administration.

About Zentalis Pharmaceuticals
Zentalis® Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing azenosertib (ZN-c3), a potentially first-in-class and best-in-class WEE1 inhibitor for patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC). Azenosertib is being evaluated as a monotherapy and in combination across multiple tumor types in clinical trials and has broad franchise potential. In clinical trials, azenosertib has been well tolerated and has demonstrated anti-tumor activity as a single agent across multiple tumor types. The Company is also leveraging its extensive experience and capabilities to translate its science to advance research on additional areas of opportunity for azenosertib outside PROC. Zentalis has operations in San Diego.

For more information, please visit www.zentalis.com. Follow Zentalis on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the potential for azenosertib to be first-in-class and best-in-class; the significance of the referenced data on the late-stage development of azenosertib; the potential benefits of azenosertib, including the potential for azenosertib to be an important treatment option for patients with ovarian cancer or other tumor types; the broad franchise potential of azenosertib; the Company’s biomarker-driven strategy for azenosertib; and the potential to advance research on additional areas of opportunity for azenosertib outside PROC. The terms “advance,” “develop,” “intent,” “look forward,” “opportunity,” “potential,” “strategy,” and “will” and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability; we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our substantial dependence on the success of azenosertib; our plans, including the costs thereof, of development of companion diagnostics; the outcome of preclinical testing and early trials may not be predictive of the success of later clinical trials; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process or ongoing regulatory obligations; our product candidates may cause serious adverse side effects; inability to maintain our collaborations, or the failure of these collaborations; our reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to intellectual property; our ability to attract, retain and motivate qualified personnel, and risks relating to management transitions; significant costs as a result of operating as a public company; and the other important factors discussed under the caption “Risk Factors” in our most recently filed periodic report on Form 10-K or 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

ZENTALIS^® and its associated logo are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release. 

Contact:
Aron Feingold
VP, Investor Relations & Corporate Communications
ir@zentalis.com  

FAQ

What azenosertib data will Zentalis (ZNTL) present at AACR‑NCI‑EORTC on October 23–24, 2025?

Four posters covering Phase 1 dose escalation/expansion results, Cyclin E1 biomarker findings, the DENALI Part 2 trial in PROC, and a trastuzumab deruxtecan + azenosertib combination study.

How do the Cyclin E1 biomarker findings affect ZNTL's azenosertib development strategy?

The company highlights Cyclin E1 biomarker data as supporting a biomarker‑driven strategy targeting Cyclin E1‑positive platinum‑resistant ovarian cancer, an underserved subgroup estimated at ~50% of PROC patients.

When and where will Zentalis present the azenosertib Phase 1 poster at the conference?

The Phase 1 dose escalation and expansion poster is scheduled for Friday, October 24, 2025, 12:30–4:00 p.m. EDT at the Hynes Convention Center in Boston.

Will the azenosertib posters be available online for ZNTL investors after the presentations?

Yes, the posters will be posted on Zentalis' Publications page on the company website on the day of the presentations.

Which clinicaltrials.gov identifiers are associated with the presented azenosertib studies?

Published identifiers include NCT04158336 for the Phase 1 study, NCT05128825 for DENALI Part 2, and NCT06364410 for the trastuzumab deruxtecan combination study.